A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/10/2018
Start Date:January 2015
End Date:February 2017

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A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis

This Phase 3 study has been designed to determine and compare the efficacy and safety of
122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque
psoriasis.


Inclusion Criteria:

- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
and no more than 12% affected body surface area.

- Subject has an Investigator's Global Assessment (IGA) score of at least three
(moderate) at study start.

- If subject is a woman of childbearing potential, she must have a negative urine
pregnancy test and agree to use an effective form of birth control for the duration of
the study.

Exclusion Criteria:

- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

- Subject has a physical condition which, in the investigator's opinion, might impair
evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
by study participation.

- Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
of photo based therapy for the treatment of their psoriasis within 30 days prior to
study start.

- Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
[including intralesional, intra-articular, and intramuscular corticosteroids],
cyclosporine or analogous products within 90 days prior to study start.

- Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
therapy) within five half-lives of the biologic prior to study start.
We found this trial at
9
sites
Arlington, Texas 76011
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Arlington, TX
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Birmingham, Alabama 35205
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Birmingham, AL
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Carmel, IN
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Detroit, Michigan 48202
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Detroit, MI
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High Point, North Carolina 27262
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High Point, NC
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Ormond Beach, FL
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Plainfield, Indiana 46168
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Plainfield, IN
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1419 Village Drive
Saint Joseph, Missouri 64506
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Saint Joseph, MO
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San Diego, California
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San Diego, CA
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